14. August 2018
A USP Stimuli article to the revision process, titled, “The Complexity of Setting Specifications for Excipient Composition and Impurities”, is published in Pharmacopeial Forum (PF) 44(3) [May-June 2018]. The Stimuli article discusses the challenges with setting specification for pharmaceutical excipients, specifically; there is no clear consensus on how to address excipient composition and impurities. The results of this survey will help USP better identify and address stakeholder overall...
05. January 2017
Abstract Microcrystalline cellulose (MCC) is used globally as an inactive ingredient in food and nutraceutical products and is commonly used as a food additive. To confirm the conformity of MCC to the solubility requirements stipulated in international specifications, the solubilities of commercially available MCC products were tested in sodium hydroxide (NaOH) solution. All of the samples were insoluble in NaOH solution, which is inconsistent with the descriptions provided in international...